Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery

Study Purpose

Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age ≥ 18 years old, regardless of gender; - Patients who plan to undergo brain lesion tissue resection surgery or have preoperative clinical diagnosis of gliomas and plan to undergo biopsy; - Patients with clinical diagnosis of initial solitary gliomas, or initial solitary intracranial masses or initial non occupying lesions that do not exclude gliomas (such as intracranial metastatic lesions, intracranial infectious lesions, intracranial demyelinating lesions, central nervous system lymphoma, etc.), who have not received radiotherapy or chemotherapy in the past based on their medical history; - The patient or their guardian can understand the research purpose, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form; - It is possible to obtain tissue samples with a length diameter greater than 0.2cm.

Patients diagnosed with initial solitary glioma should take core or marginal tissue, while patients diagnosed with initial single intracranial mass or initial non mass lesions but maybe with gliomas should be taken core tissue.

Exclusion Criteria:

- Investigator judge that it is not suitable for inclusion.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05901844
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tao Jiang, MD and PhDQing MaoDongming YanShouwei Li
Principal Investigator Affiliation	Beijing Tiantan HospitalWest China HospitalThe First Affiliated Hospital of Zhengzhou UniversityCapital Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Additional Details

Based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. Compare the results between the Raman analyzer and the paraffin pathological. And calculate the sensitivity, the specificity, and other indicators of Raman analyzer. During surgery, core or marginal tissue samples were taken from subjects. The test samples size:0.2cm

Arms & Interventions

Arms

Other: Perform two different tests on the same sample

The same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology.

Interventions

Diagnostic Test: - Paraffin pathological diagnosis

Perform two diagnostic methods on the same sample

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Tao Jiang, MD and PhD

[email protected]

+86 10 67021832

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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